Safety and tolerance of enteric-coated mycophenolate sodium in patients after kidney transplantation – an observational study
J Gozdowska, T Bączkowska, J Pazik, B Matłosz, T Cieciura, J Szmidt, A Chmura, M Durlik
Ann Transplant 2009; 14(1): 75-75
Available online: 2009-05-21
Background: Enteric-coated mycophenolate sodium (MPS) has been developed as an alternative agent to mycophenolate mofetil (MMF), with aim to provide reduction in gastrointestinal (GI) complications.
Material/Methods: Between February 2006 and December 2007, 74 patients,
mean age 42.26 years, in whom MMF was switched to MPS were included in
the study. The mean time from transplantation to change in treatment was 3.69 years. Follow-up was 3 months (Visit 0, Visit 2 after 1 month and Visit 3 after 3 months). During Visit 2 and 3, the impact changing the treatment on the severity of GI symptoms was assessed on a scale from 1 to 4 (1 - wors-ening, 2 - no change, 3 - improvement, 4 - resolved). Tolerance of therapy, patient compliance and physician's satisfaction with treatment were also assessed (1 to 4 scale: 1 - bad, 2 - fair, 3 - good, 4 - very good). During Visits 2 and 3, adverse events (AEs) were recorded.
Results: Follow-up was completed in 63 patients (85.1%). Patients received MPS in doses ranging from 720 to 1440 mg (mean dose 1092 mg). The mean GI symptom severity score in the MMF to MPS conversion group was 3.41. The most common symptoms that were the reason for conversion were: abdominal pain, diarrhoea, abdominal colic, nausea, anorexia and vomiting. Out of 175 reported complaints 144 (82%) either improved or were completely resolved. Worsening was noted with regard to only 5 (2.86%) of reported complaints, and no change was seen in 25 (14.86%) symptoms. Patient's compliance was graded as 3.70 for Visit 3. Mean physician's satisfaction score assessed during the last visit was 3.02. 9 AEs (including 2 severe) were reported. Causal relationship with the medication was suspected in 5 cases (including 1 case of SAE). The most important AEs were: anaemia, infection (including 1 case of sepsis), GI symptoms (abdominal pain, diarrhoea).
Conclusions: 1. Sodium mycophenolate is well tolerated. 2. After switching from MMF to MPS, gastrointestinal symptoms decrease. 3. MPS is a safe
medication, with a low adverse event rate.
Keywords: Immunosuppression, Kidney Transplantation, clinical outcome